If there’s one thing that unites all countries and cultures, it’s our love of caffeine. Whether it’s coffee, tea or other foods, caffeine is the most widely consumed drug in the world — more than alcohol, and more than tobacco: 90% of adults worldwide consume caffeine daily. At doses found in food and beverages, the effects are predictable and the side effects are slight. But natural or not, caffeine is a drug; isolate the pure substance, and the risks change. It would be difficult for most people to drink 16 cups of coffee in a row, but that’s the equivalent of just one teaspoon of caffeine powder. If that doesn’t hospitalize you, a tablespoon of the powder will probably kill you. Yet despite the risks, there are no restrictions on the sale of caffeine powder. You can buy a 1kg bag for $35, which provides the caffeine of about 5,000 cups of coffee. Caffeine powder is freely available to buy because regulators treat it differently – not because of its inherent properties, but because it’s “natural” and sold as a dietary supplement rather than a drug. This is a regulatory double-standard that harms consumers. It’s leaving a body count. And it needs to change: (more…)
Archive for Politics and Regulation
The FDA recently announced it would send field staff out to collect samples of commercially-manufactured raw dog and cat food. The samples will be analyzed for Salmonella, Listeria monocytogenes and E. coli, all of which have been found in raw pet food, in the animals who eat it, in their feces, on their bodies after eating it, in the areas they inhabit, and on their owner’s bodies. Not surprisingly, this has led to both pet and human infection and illness. If the FDA finds pathogens, it could result in a recall, a press release and Reportable Food Registry Submission. The next day, the CDC joined the effort to curb illness caused by pathogens in raw pet food by posting information on safe handling.
Because of the risk to public health, and the lack of any proven benefit of raw pet food diets, the FDA does not recommend them.
However, we understand that some people prefer to feed these types of diets to their pets.
And why is that? For some of the same reasons humans follow absurd diet fads: the “lone genius” discovery, it’s “natural,” anecdotal evidence, appeal to antiquity, anti-corporate sentiment, and “holistic” practitioner recommendations.
On April 21 and 22, the FDA held a public hearing:
to obtain information and comments from stakeholders about the current use of human drug and biological products labeled as homeopathic, as well as the Agency’s regulatory framework for such products. . . . FDA is seeking participants for the public hearing and written comments from all interested parties, including, but not limited to, consumers, patients, caregivers, health care professionals, patient groups, and industry.
The FTC recently announced that it, too, is wading into the homeopathic waters. The FTC, which regulates advertising of homeopathic products, will hold a public workshop on September 21 in Washington, DC, “to examine advertising for over-the-counter (OTC) homeopathic products.” Like the FDA, it will also accept public comments online.
All of this regulatory buzz caused the FDA Law Blog to take notice. (The blog is hosted by a law firm specializing in food and drug regulation law.) A post titled “Will FTC Kill Homeopathic Products – or Will FDA?” gave this assessment:
Bottom line, if the FTC holds homeopathic products to the same scientific standards that are applied to claims for other OTC products like dietary supplements, as the FTC appears inclined to do . . . few if any homeopathic products will pass the test.
Today the UK Parliament will have a vote for the chair of the Health Select Committee. The two choices could not be more starkly different, so much so that this vote might be seen as a referendum on two world views, one that respects science and another that confuses pseudoscience and spirituality for medicine.
On one side we have Sarah Wollaston, the previous chair, who is a former general practitioner and has taken a solid stand against pseudoscience in medicine. She has previously tweeted, for example, “Homeopathy can also have serious harms when masquerading as a ‘vaccine’.”
Tredinnick, on the other hand, has previously argued that the NHS should incorporate astrology into the healthcare system. I have previously argued that homeopathy is the most absurd and easily debunked major form of alternative medicine. Astrology, however, is arguably more absurd, I had just never heard it offered as a basis for healthcare. Tredinnick has at least accomplished setting a new low bar for alternative medicine nonsense.
Tredinnick appears to be a true-believer, fully steeped in the propaganda that is CAM (so-called complementary and alternative medicine). He has said:
Ninety per cent of pregnant French women use homeopathy. Astrology is a useful diagnostic tool enabling us to see strengths and weaknesses via the birth chart.
And, yes, I have helped fellow MPs. I do foresee that one day astrology will have a role to play in healthcare.
As I write this, I am currently at the Center for Inquiry (CFI) Reason for Change conference, where on Friday Steve, Harriet, and I did a panel on—what else?—alternative medicine and how it’s become “integrative medicine.” As a result, I’ve been very busy, which means that parts (but by no means all) of this post will look familiar to those of you who follow me at my not-so-super-secret other blog. However, it occurred to me after we did our panel discussion that there are important things happening in California that we’ve only barely touched on here on this blog. I’m referring, of course, to a bill (SB 277) that’s wending its way through the California legislature. SB 277, if passed, would eliminate nonmedical exemptions to school vaccine mandates. That’s not to say we haven’t discussed the issue of nonmedical exemptions, of which there are two types: religious and personal belief exemptions (PBEs), which can all be simply described as PBEs. Both Steve Novella and I have addressed them on SBM. For example, when an earlier bill (AB 2109) was passed that mandated that parents seeking PBEs consult with a physician or other listed health care professionals (which, unfortunately, included naturopaths) before a PBE would be granted, I documented how the antivaccine movement strenuously objected even to this minor tweak in the law that would make PBEs slightly more difficult to obtain. Unfortunately, even though, against all expectations, the bill passed, Governor Jerry Brown sabotaged it with a signing statement that betrayed California children by reinstating, in essence, religious exemptions. Specifically, Gov. Brown ordered the California Department of Public Health to include a check box on the form that parents could check to say they have religious objections to vaccines. Parents who checked that box could thus bypass even the anemic requirement to consult with a pediatrician before being granted a PBE.
The problem with nonmedical exemptions to school vaccine mandates is that vaccine-averse and antivaccine parents tend to cluster mostly in areas where white, affluent people live, as demonstrated in California and my own state of Michigan. So, even though antivaccinationists frequently tout high statewide vaccination rates as evidence that the process for obtaining PBEs does not need to be tightened up, they are disingenuously using a straw man argument against vaccine mandates, because it’s the pockets of low vaccine uptake that compromise local herd immunity that are the problem. We see these in Oregon, California, Michigan, and many other states with PBEs, and we also know that ease of obtaining PBEs is correlated with more PBEs and more outbreaks of vaccine-preventable diseases.
All of this came to a head earlier this year with what is now known as the Disneyland measles outbreak, a large multistate outbreak originating at Disneyland and traced to unvaccinated children. This outbreak so shocked California that the unthinkable happened. The possibility of passing a law eliminating nonmedical exemptions to vaccine mandates, something virtually everyone would have considered as much a fantasy as many of the characters played by the recently deceased great Christopher Lee played during his career, suddenly became an attainable goal. Senators Richard Pan and Ben Allen introduced SB 277, which would eliminate the personal belief exemption for children attending state licensed schools, daycares, and nurseries in California.
Over the years, our bloggers here at Science-Based Medicine have written time and time again about the intersection of law and science in medicine. Sometimes, we support a particular bill or law, such as laws to protect children against religion-inspired medical neglect; laws making it harder for manufacturers of homeopathic “medicines” to deceive the public; or California Bill AB 2109, a bill whose intent was to make it more difficult for parents to obtain nonmedical exemptions to vaccine mandates but whose implementation after being passed into law was profoundly sabotaged by Governor Jerry Brown. or, more recently, California SB 277, a bill currently wending its way through the California legislature that would eliminate nonmedical exemptions to school vaccine mandates and has, not surprisingly, engendered extreme resistance from the antivaccine crowd, including by Robert F. Kennedy, Jr. In the vast majority of cases we explain how the law lets us down when it comes to science in medicine, and, unfortunately, examples are many: Naturopathic licensing laws; supplement regulation (or, more appropriately, lack of regulation); misguided, deceptive, and patient-hostile “right-to-try” laws; state laws regulating medical practice that allow quackery to flourish unchecked; laws regulating pharmaceutical cost transparency that ask the wrong question.
The case I will discuss here is unusual in that it is a case of the law getting ahead of what the science says in a manner that will likely do little, if any, good for patients, cause a lot of confusion until the science is worked out better, and end up costing patients money for little or no benefit. I am referring to laws mandating the reporting of high-breast-density to women with dense breasts undergoing mammography. These laws are sweeping the country (albeit not as rapidly as “right-to-try” laws), with a total of 22 states having passed them as of today since Connecticut became the first to do so in 2009. The most recent of these laws went into effect in my own state of Michigan exactly one week ago:
Women with dense breast tissue — the sort that can hide potentially deadly tumors from routine mammograms — must be notified in writing and encouraged to consider additional tests under a new state law that is effective Monday.
While mammograms remain the gold standard for detecting breast tumors, they’re less reliable in almost half of women with dense breast tissue. Dense or fibrous tissue shows up as splotches of white on a mammogram — so do tumors.
That will likely surprise many of the millions of women who rely on mammography for catching the earliest signs of cancer, said Nancy Cappello. The Connecticut woman was shocked in 2004, when her gynecologist found a lump — advanced cancer that had already spread to her lymph nodes — just months after a mammogram deemed her cancer-free.
Brian Clement is a charlatan. Unfortunately, that doesn’t seem to be a problem for the State of Florida. I made two (which turned into three) attempts to get the state to take action against Clement or the Hippocrates Health Institute, where he serves with his wife Anna Maria Gahns-Clement as co-director. All of them failed. Brian Clement slithered through the cracks in Florida law each time.
Before we get into the details of Florida’s failure to act, a bit of history (and there is plenty of it) is in order.
In recent months, Clement’s sordid cancer quackery has been well-documented in the media as well as in the science “blogosphere”. (I’ve listed what I hope is a — but almost certainly isn’t — complete blog archive at the end of this post. Many of the Canadian Broadcasting Corporation [CBC] and other news reports are linked in these posts.) Most of the coverage has centered on two Canadian girls suffering from lymphoblastic leukemia whose parents pulled them from conventional cancer therapies, which gave them an excellent chance of survival, in favor of treatment at the Hippocrates Health Institute (HHI), a sprawling spa in West Palm Beach, Florida, licensed as a massage establishment by the state.
Clement gave a talk in Canada, in 2014, claiming “we’ve had more people reverse cancer than any institute in the history of health care.” (“We” is the operative word here, because it later served as Clement’s ticket to avoid prosecution by the Florida Board of Medicine, as you shall soon find out.) The girls’ families were impressed.
Sadly, one of the girls, Makayla Sault, died earlier this year. The other, identified only as “JJ” in the media because of a publication ban, has returned to conventional treatment. However, her mother apparently remains under the influence of Clement: JJ is restricted to a raw foods diet and is still being followed, if that is the right word, by HHI. (more…)
When I wrote a week ago about the sham that is “right-to-try”, one criticism (among many) that I made of these misguided, profoundly patient-unfriendly laws was that I have as yet been unable to find a single example of a patient who has managed to obtain access to an experimental therapeutic through such a law, much less been helped by it. So-called “right-to-try” laws, of course, claim to provide a mechanism by which patients with terminal illnesses can obtain access to experimental therapeutics not yet approved by the FDA but still in clinical trials. They are, as I’ve pointed out, a cruel sham, placebo legislation that makes lawmakers feel as though they’ve done something good but do nothing of substance for patients while providing them with false hope. The federal government through the FDA controls drug approval, which means that states can’t compel a drug company to provide a drug to a patient, and most drug companies would not want to risk jeopardizing approval of their drug, which is what could happen if they grant access to an investigational drug under right-to-try and the patient suffers an adverse event. After all, the success rate for drugs that have passed phase 1 (which is all that right-to-try requires) in phase 3 trials is only on the order of 9-12%, meaning that that’s the most optimistic probability that such drugs would benefit a patient. In reality, it’s almost certainly much, much lower.
If science-based medicine is unaffordable, then your care won’t be science-based. Prescription drug costs are one of the biggest concerns in health care today. There seems to be no upper limit on prices, with some new treatments costing over $1,000 per day. The arrival of new drugs to treat (and cure) hepatitis C has created a perfect pharmaceutical storm: highly effective treatments, a large population of potential patients, and huge per-patient costs. It’s renewing the debate about whether important medical treatments are being priced out of the reach of the patients that need them. It’s not just hepatitis. Cancer drug costs are rising as well, driven by more patients and new drugs that in some cases are transforming our expectations about what cancer drugs can do. And while many of us rely on some form of drug insurance to protect us from high drug costs, insurers are struggling with balancing coverage and premiums: A report by Express Scripts paints a grim picture:
An estimated 576,000 Americans spent more than the median household income on prescription medications in 2014. This population of patients grew an astounding 63% from 2013. Further, the population of patients with costs of $100,000 or more nearly tripled during the same time period, to nearly 140,000 people. The total cost impact to payers from both patient populations is an unsustainable $52 billion a year.
This isn’t just an issue in the United States. Prescription drug costs are climbing around the world, because we’re effectively all in this together: We all rely on private companies to bring new drugs to market, and we’re largely buying the same drugs from the same small group of companies. Because ready access to safe and effective prescription drugs is so important to the practice of medicine and the delivery of health care, the pharmaceutical industry is heavily regulated – not just by the FDA, but by regulators worldwide. Yet despite the dual requirements of regulatory disclosure and the financial obligation to be transparent (as many pharmaceutical companies are publicly-held), little is known about how much it costs to bring drugs to market, and how manufacturers arrive at their selling prices. Pharmaceutical manufacturers claim that high drug costs reflect the high costs of research and development (R&D), and provide the incentives for companies to invest heavily and take risks, when many drugs may never make it to market. Are they correct? (more…)
A cycling enthusiast asked me about helmets. It seems compellingly obvious to me that a head impacting the pavement without a helmet is likely to sustain more damage than a head protected by a helmet. He challenged that, citing a BMJ article by Ben Goldacre that questioned whether the evidence showed that helmets do any good. He said I was making a non-evidence-based assumption and challenged me to actually look at the evidence, so I did.
Goldacre says there is a:
complex contradictory mess of evidence on the impact of bicycle helmets. Like most places where there’s controversy and disagreement, this is a great opportunity to walk through the benefits and shortcomings of different epidemiological techniques, from case control studies to modeling.
He proceeds to give a lesson in epidemiology. He points out that there are a lot of emotion involved, and that epidemiologic studies, because of their inherent imperfections, are probably not capable of resolving the debate.
There are basically two questions:
- What is the effect of wearing a helmet for the individual?
- What is the effect of a public policy that promotes or requires helmet use?